Insight: Biology Of A Meningococcal Vax Company

Chiron Corporation.
Does that name a ring a bell? In North America, it’s
gone from barely known to highly recognized in less than a
month since 45 million doses of flu vaccine made by the
company in its British factory, were found to be
contaminated. In Brazil the company made headlines when over
5 million doses of a vaccine were recalled following serious
adverse reactions.

New Zealanders will be familiar with
Chiron Corporation – It is the company overseeing our
meningococcal B vaccine (MeNZB™) trials. They are also
manufacturing the vaccine and selling it back to our
government. Aside from the conflicts of interest inherent in
this arrangement, Chiron’s problems in North America and
Brazil surfaced after New Zealand experts, prior to the
approval of the MeNZB™ vaccine, had expressed concerns.

While the flu vaccine saga is a maze of PR
pronouncements, public assurances, backtracks, and yet more
spin, the company has just received a grand jury subpoena.
The newspaper USA Today said the subpoena raises the stakes
in the USA's flu vaccine crisis to a possible criminal
matter. Legal experts said the Justice Department might be
looking for evidence of securities fraud -whether the
company intentionally misled investors. The department could
also be investigating whether Chiron lied to a government
agency, such as the Food and Drug Administration (FDA),
legal experts said.

A small war has flared up between
the FDA and Britain’s Medicines and Healthcare products
Regulatory Agency (MHRA). The MHRA said they warned their
American counterparts about on-going problems with Chiron in
August. British officials also said that the United States
"should have realized the potential scale" of problems at
the Liverpool plant long before the announcement of the
suspension of Chiron's license. But as the New York Times
reported recently contamination problems at the factory were
not new. Polio vaccines manufactured by a previous owner
were recalled in October 2000 after fears of BSE (Mad Cow
disease) contamination. While a previous flu vaccine
manufacturer also had contamination problems at the same
factory in 1999. It has been noted that the adverse events
following immunization with Chiron’s MMR vaccine in Brazil
were from a vaccine made in the same Italian factory that
produces New Zealand’s experimental MeNZB™ vaccine.

The
UK Guardian characterized the FDA’s reaction to the Chiron
flu vaccine contamination as ‘hand-wringing about why it
didn’t act earlier.’ But then given other recent situations,
such as the documents discovered by The Wall Street Journal
that show safety concerns surrounding Vioxx use have been
systematically covered up since at least 2000, to a string
of other cases where the agency failed to safeguard the
public, it’s not surprising. In a recent expose in Harpers
Magazine the situation was described succinctly as the FDA’s
‘deference to drug companies.’ Meanwhile the Financial Times
of London and The Washington Post reported that the US
Senate Finance Committee is expanding its probe of the FDA
and its secret deals with drug manufacturers.

In New
Zealand, the medicines watchdog, MedSafe, has received 60%
more reports of adverse effects relating to Vioxx’s
competitor, Celebrex, than Vioxx, and yet, paradoxically
says there is no official evidence of Celebrex being unsafe,
or any intention to take the findings further.

The
Chiron debacle does have an upside. It has given the public
an insight into how a biotech company works to spin its woes
into gold and how little stands in the way of Chiron’s drive
for shareholder profit (last year vaccines accounted for
about US $700 million of Chiron’s US $1.75 billion in
revenue). It’s also given an insight into the cosy
relationship between the regulators and their clients, the
pharmaceutical industry.

In New Zealand documents
obtained under the Official Information Act show that the
New Zealand Medicines Assessment Advisory Committee (MAAC),
appointed by the Minister to advise her on the licensing of
new drugs, had concerns about the manufacturing and quality
of the MeNZB™ vaccine. While the Committee noted that there
are a “…number of issues relating to the manufacturing and
quality data that are to be addressed by Chiron,” the
Minister approved the license for the MeNZB vaccine under
the fast-track section 23 of the Medicines Act the very next
day. Section 23 allows for license of experimental drugs for
“restricted use and limited numbers of patients.”

Despite the concerns, MedSafe arbitrarily extended the
expiry date on 390,000 doses of the MeNZB™ vaccine so that
it could be used in the vaccination program. Paradoxically,
MedSafe’s website advises consumers not to have the MeNZB™
vaccine if “the expiry date printed on the pack has passed.”

The minutes of the MAAC meeting show that the
teleconference meeting was called at such short notice that
several of the committee of could not be contacted, and
several others had not received the clinical data upon which
the approval decision was based. The media had mentioned the
planned meeting two weeks earlier.

When the Minister was
asked in Parliament if she had confidence in the MAAC
recommendation, she said that she didn’t have to because the
New Zealand vaccine data had been given the nod by the UK’s
MHRA.

This is the same MHRA that sat on evidence of
SSRI drugs, such as Aropax, causing an increase in the risk
of youth suicide for more than a decade without taking
regulatory action, and which is a central figure in the UK
Parliament's current inquiry into the influence of the
pharmaceutical industry on healthcare.

The situation
with Chiron is far from reassuring for the 1.15 million
children presently being immunized with the experimental
MeNZB™ vaccine in New Zealand. While immunization is still
voluntary in New Zealand, spend any time at a school in
South Auckland and you’ll discover the pressure to immunize
feels very compulsory. Combine that with a lack of
information other than MOH glossy brochures and the lack of
critical analysis of the MeNZB™ vaccine in the mainstream
media or even publicizing of information like the fact that
every year about 350 New Zealand children aged under two,
die from all causes; 99.5% of them unrelated to
meningococcal disease.

The minister has confirmed in
Parliament that meningococcal disease is naturally
declining. This year the death rate is about 75% less than
peak levels. And yet in the same breath the minister says
this is not significant and does not represent evidence that
the epidemic is abating. At the same time, the Land
Transport Safety Authority was publicly crowing about the
success of its ‘anywhere, anytime’ speed camera policy;
claimed to have resulted in a “significant” 12% decline in
road deaths. The Ministry of Health’s own data shows that
meningococcal disease cases are at 10 year lows; deaths are
at thirteen year lows and yet the minister continues to deny
that there is any evidence that the epidemic is abating
naturally.

Interestingly MAAC noted that the benefits of
the MeNZB™ vaccine only applied in the Auckland context, yet
the mass vaccination experiment is still being rolled out
nationwide and given the Ministry of Health’s own data, is
unlikely to prevent more than 1 or 2 deaths out of a total
of 27,000 deaths in New Zealand each year.

At this
stage one wonders just where the MOH should go to seek
reassurance that its $250 million investment is not lost.
Neither Chiron nor those running the trials with Chiron’s
money seem to be a good choice. That leaves MedSafe. But
like the FDA and the MHRA, their conflicted political
agendas may not, in fact make them the best judge of a
vaccine’s safety or effectiveness.

Official press
releases continue to assure parents that the MeNZB™ vaccine
is not only needed, but safe. On 7 July the minister stated,
“MedSafe is assured that the vaccine is safe and
effective...” A day earlier, the MAAC said that it ‘appeared
to be’ effective ‘in the Auckland context, ’ and a few weeks
before that the MOH said that rollout of the programme will
occur knowing that MeNZB™ is immunogenic “but without
efficacy data.” That means they don’t actually don’t know if
it’s effective. A number of observational studies are
planned post-licensure to assess effectiveness of the
vaccine, but the dramatic ongoing declines in meningococcal
disease case numbers and deaths occurring naturally will
complicate that exercise.

The big question is of
course: just where do parents go for the objective
reassurance they so desperately need?

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